Pharmaceutical Quality Congress Presentations

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Pre-Conference Workshop: Wednesday, June 14, 2017

1:00 p.m. - 4:00 p.m.

Data Integrity Problems on the Rise: Ensuring Quality through Data Integrity

Leo Dodds, Principal Consultant, QuintilesIMS
Pamela Weagraff, Director, Medical Device & Diagnostics Regulatory, QuintilesIMS

   
Day 1: Thursday, June 15, 2017

9:00 a.m. - 9:45 a.m.

FDA’s Quest for Quality (No Slides)

Howard Sklamberg, Principal, Sklamberg Strategies LLC

9:45 a.m. - 10:30 a.m.

What’s Going on Out There

Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.

10:45 a.m. - 12:00 p.m.

Data Integrity: A Structural Approach to Compliance

John C. (Jack) Garvey, Principal, Chief Executive Officer, Compliance Architects®

1:00 p.m. - 1:45 p.m.

Top 5 Annual 483 Observations: The Cycle of Quality

Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.

1:45 p.m. - 2:30 p.m.

Quality Metrics: What Do You Have To Report

Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.

2:45 p.m. - 3:30 p.m.

PDA Quality Culture Assessment Pilot Program

Denyse Baker, Senior Advisor of Scientific and Regulatory Affairs, PDA
Susan Schniepp, Fellow, Regulatory Compliance Associates Inc.

3:30 p.m. - 4:30 p.m.

Ask The Experts: Real-World Advice on Running Quality Programs (No Slides)

Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf
Steve Lynn, Global Head of Corporate Compliance and Audit, Novartis International
Zena Kaufman, Vice President of Quality, Roivant Sciences

   
Day 2: Friday, June 16, 2017

9:00 a.m.-9:45 a.m.

Creating a Quality Culture to Aid Risk Management

Teresa Gorecki, Practice Lead, Compliance Architects®

9:45 a.m.-10:30 a.m.

Diving Deep – Understanding More of the Pharmaceutical Supply Chain in 2017

Gerard Pearce, Executive Vice President, SQA Services, Inc.

10:45 a.m.-12:00 p.m.

Panel Discussion: Quality Regulation Harmonization — The US and EU Mutual Recognition of Drug Manufacturing Inspections

David Elder, EVP, Regulatory Compliance, Greenleaf Health LLC
Cynthia Schnedar, Executive Vice President, Regulatory Compliance, Greenleaf
Howard Sklamberg, Principal, Sklamberg Strategies LLC